Kornimate/medical-research-clean huggingface dataset:
comparative study, safety and efficacy, ahmed glaucoma drainage device, model m4 model s2 in neovascular glaucoma

Conditions: Neovascular Glaucoma

Summary: objective: prospectively evaluate the safety and efficacy of the ahmed glaucoma drainage device, model m4 compared with the model s2. method: mexican patients with neovascular glaucoma will be randomly included for each group (m4 and s2). they will be operated using conventional techniques and creating a sub-episcleral tunnel to place the valve's tube in the anterior chamber. they will be monitoring for one year and the results will be evaluated with respect to a postoperative reduction in pressure, changes in visual acuity, the need for drugs and complications, in addition to the demographic characteristics of each group.


Eligibility criteria:
inclusion criteria: * patients with diagnosis of neovascular glaucoma * high iop despite topical treatment exclusion criteria: * pregnant women * mental disorders * previous glaucoma surgery * patients older than 18 years

Keywords: ahmed implant neovascular glaucoma intraocular pressure
is regional anesthesia of the hip preferable over traditional analgesia in the acute stage of the management of patients with a fracture of the hip

Conditions: Hip Fractures

Summary: the main hypothesis of the study is that anaesthesia of the hip using infiltration with a local anesthetic solution is preferable over traditional analgesia with oral opioid medications in the acute stage of the management of patients with a fracture of the hip. to study the hypothesis the investigators designed a prospective randomised study where patients are assigned in two groups, the first receiving local hip anesthesia and the other placebo treatment. both groups are eligible to use of standard oral pain treatment. effect of analgesia as well as medical complications will be recorded.


Eligibility criteria:
inclusion criteria: * fracture of the hip exclusion criteria: * multiple fractures, * delay (more than 12 hours) from the time of injury until admission to the hospital, * local infections, hypersensitivity to local analgetics, * cognitive impairment
sympathetic overactivity in essential hypertension

Conditions: Hypertension; Proteinuria

Summary: the primary objective of the study is whether subjects with hypertension and proteinuria display increased sympathetic nerve activity compared to hypertensive subjects without proteinuria and normotensive controls.


Eligibility criteria:
inclusion criteria: * normotension or hypertension exclusion criteria: * pregnant and nursing women * myocardial infarction, clinical signs of coronary heart disease * severe depression

Keywords: hypertension sympathetic activity early renal damage
clinical evaluation of extended depth-of-focus intraocular lens in refractive cataract surgery: a randomized controlled trial

Conditions: Cataract

Summary: the goal of this clinical trial is to compare the clinical outcomes of two extended depth-of-focus intraocular lens after cataract surgery. the randomized controlled trail will enroll 90 participants. the participants will be randomly assigned to implant tecnis synergy zfr00 or tecnis symfony zxr00 intraocular lens. follow-up visit will be performed till 3 months postoperatively to compare the visual acuity, subjective manifest refraction, and visual quality between groups.


Eligibility criteria:
inclusion criteria: * age-related cataract patients aged between 40 to 80 * patients with preoperative astigmatism less than 0.75 d, and kappa value less than 0.7 mm * patients who plan to receive femtosecond laser-assisted cataract surgery exclusion criteria: * patients with ocular surface abnormalities such as irregular corneal astigmatism, corneal scarring, keratoconus, and pterygium) * patients with history of ocular trauma or surgery * patients with coexisting ocular disorders such as glaucoma, retinal vascular occlusive disease, retinal detachment, diabetic retinopathy, and any optic nerve-related pathologies * patients with concurrent severe systemic diseases * patients who lack of cooperation

Keywords: cataract surgery intraocular lens extended depth-of-focus
respiratory physiology in children with febrile seizures.

Conditions: Febrile Illness in Children; Seizures, Febrile

Summary: febrile seizures occur in 2-5% of the population and are typically limited to children between 3 months and 5 years-of-age. the pathophysiological link between increased body temperature and increased seizure susceptibility is unsolved in humans. in a mouse model it has been shown that young animals had a tendency to hyperventilate thereby causing intra-cerebral hypocapnia / alkalosis and a decrease of their seizure threshold. this effect was not observed in older animals. redressing the pco2 (carbon dioxide partial pressure) by breathing carbon dioxide enriched air instantly stopped the seizures. in this study the investigators want to investigate the respiratory physiology in children with febrile seizures and compare it to children who have fever but did not have febrile seizures. the investigators hypothesize that in children with febrile seizures the rising body temperature triggers a larger increase of respiratory rate (hyperventilation) and subsequent drop in pco2 levels. this study could provide the basic physiological data for an interventional trial to test the efficacy of carbon dioxide inhalation to interrupt febrile seizures.

the aim of the study is the continuous non-invasive monitoring of * body temperature * respiratory rate * transcutaneous pco2 * heart rate * pulsoxymetric sao2 (arterial oxygen saturation) during a febrile illness * in children without febrile seizures and * in children who had suffered a febrile seizure during the actual febrile illness. children will be recruited from the emergency units of the charité university hospital and a large community hospital, matched according to age, gender and the cause of their febrile illness and their data will enter final analysis if their body temperature rose at least once to or above 38.0 degree c and changed more than 1.0 degree c during the observational period.

Eligibility criteria:
inclusion criteria: * febrile illness with body temperature ≥38.0 degree c * 50% of study population: never had a febrile seizure * 50% of study population: simple or complex febrile seizure within one day of investigation * change of body temperature of ≥1.0 degree c during the monitoring period * provision of written informed consent by the parents or guardians of the child * artefact-free simultaneous measurement of respiratory rate, pco2 (transcutaneous probe), body temperature (rectal probe), and heart rate during change of body temperature of ≥1.0 degree c. exclusion criteria: * past history of afebrile seizures * past history of neonatal seizures * retarded psychomotor development * chronic respiratory disease * cardiologic disease * severe other organ disease * permanent medication for chronic disorder * therapeutic increase of inspiratory oxygen concentrations during the observational period

Keywords: febrile seizure respiratory physiology respiratory drive respiratory alkalosis
the feasibility of vr for oud

Conditions: Opioid Use Disorder

Summary: this study aims to evaluate feasibility of a virtual reality software device and measure the effects of the intervention on oud patient mood, tension and cravings, as well as the effect of treatment on patient retention to their inpatient detox protocol.

the primary objective of this study is to evaluate the feasibility and preliminary effectiveness of a novel virtual reality (vr) based intervention; 3d therapy thrive (3dtt). inpatient detoxification can improve outcomes for individuals with opioid use disorder (oud), however patients often leave treatment early due to mood, tension, and cravings associated with opioid withdrawal. subjects were recruited from a community inpatient detoxification program and received up to two sessions of 3dtt. the patients completed surveys to assess their mood, distress, cravings, and overall satisfaction with the experience. retention was measured by protocol completion as reported by clinic staff, independent of the study. a group of patients with oud consecutively admitted to the program comprised a comparison treatment-as-usual (tau) group.

Eligibility criteria:
inclusion criteria 1.18 years or older 2. current diagnosis of opioid use disorder 3. current inpatient in detox ats unit 4. fluent in english exclusion criteria 1. active suicidality 2. history of seizures 3. history of psychosis 4. severe visual impairment

Keywords: mood cravings retention
treatment of venous thromboembolism (vte) with either rivaroxaban or current standard of care therapy

Conditions: Deep Vein Thrombosis (DVT); Pulmonary Embolism (PE)

Summary: following the findings of the clinical trials in drug development, this global non-interventional cohort field study will investigate rivaroxaban under clinical practice conditions in comparison with current standard of care for patients with acute venous thoromboembolism (vte). the main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute vte in routine clinical practice.


Eligibility criteria:
inclusion criteria: * female or male patients, who are at \>=18 years * diagnosis of acute dvt and/or pe, objectively confirmed * indication for anticoagulation therapy for at least 12 weeks * willing to participate in this study and available for follow-up exclusion criteria: * exclusion criteria must be read in conjunction with the local product information.

Keywords: thromboembolism embolism and thrombosis vascular diseases cardiovascular diseases thrombosis
federal study of adherence to medications in the elderly (fame)

Conditions: Medication Adherence; Hypertension; Hyperlipidemia

Summary: the purpose of this study is to determine the effect of a comprehensive pharmacy care program on medication adherence and persistence, blood pressure, and ldl cholesterol.

poor medication adherence is prevalent, difficult to manage, and diminishes the health benefits of pharmacotherapies. elderly patients with coronary risk factors frequently require treatment with multiple medications which places them at increased risk for medication nonadherence. effective strategies to improve adherence in the elderly are lacking, and improved health outcomes in this population have not been demonstrated. objective: we tested the efficacy of a comprehensive pharmacy care program including patient education and an adherence aid (medications custom-packaged in blister packs) to improve medication adherence and its associated effects on blood pressure and low density lipoprotein cholesterol. this is a multi-phase, prospective observational and randomized controlled trial. we enrolled community-based patients aged ≥ 65 years old taking ≥ 4 chronic medications per day. intervention: after a 2-month run-in phase during which baseline medication adherence (via pill counts), blood pressure, and low-density lipoprotein cholesterol were measured, participants entered a 6-month intervention phase during which standardized medication education and regular follow-up by a clinical pharmacist was provided and medications were dispensed in daily, time-specific blister packs. following the intervention phase, participants were randomized to continued pharmacy care/blister packs versus usual care (return to their original method of medication administration) for an additional 6 months. main outcome measures: the primary endpoint of the observation phase was the change in the proportion of pills taken compared to baseline; secondary endpoints were the associated changes in low-density lipoprotein cholesterol and blood pressure. the primary endpoint of the randomized trial was the between-group comparison of medication persistence analyzed according to intention to treat.

Eligibility criteria:
inclusion criteria: * 65 years or older taking 4 or more chronic medications independently living exclusion criteria: * assisted living or nursing home residents presence of any serious medical condition for which 1-year survival was expected to be unlikely

Keywords: hypertension hyperlipidemia adherence pharmacist elderly medication
phase iii clinical trial of travatan z in ocular surface health

Conditions: Open-angle Glaucoma; Ocular Hypertension

Summary: the purpose of the study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * 18 years or older. * ocular surface disease index (osdi) score and corneal fluorescein staining score as specified in protocol. * diagnosis of open-angle glaucoma or ocular hypertension in at least one eye. * intraocular pressure (iop) controlled with latanoprost 0.005% (xalatan®) for at least one continuous month prior to visit 1. * willing and able to discontinue use of any topical ocular medicine other than the study medication for the duration of the study, including artificial tears. * best corrected visual acuity of -0.6 logmar or better in each eye. * other protocol-defined inclusion criteria may apply. exclusion criteria: * any medical condition (systemic or ophthalmic) that may preclude safe administration of the test article. * use of contact lenses within 30 days of visit 1. * use of contact lenses during the study. * participation in an investigational drug or device study within 30 days of entering this study. * other protocol-defined exclusion criteria may apply.

Keywords: open-angle glaucoma ocular hypertension
correlation between circulating resistin and vascular inflammation measured by 18f-fluorodeoxyglucose (fdg) positron emission tomography (pet) (18fdg-pet)

Conditions: Atherosclerosis

Summary: vascular inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis.resistin was shown to induce vascular endothelial dysfunction and vascular smooth muscle cell proliferation. 18f-fluorodeoxyglucose (fdg) positron emission tomography (pet) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques.therefore, the purpose of the study is to demonstrate the correlation between circulating resistin and vascular inflammation detected by 18fdg-pet in obese persons.


Eligibility criteria:
inclusion criteria: * healthy volunteers for visiting routine medical check in our clinic exclusion criteria: * history of cardiovascular disease (myocardial infarction, unstable angina,stroke, or cardiovascular revascularization) * diabetes * hypertension * malignancy * severe renal or hepatic disease * subjects taking medications that might affect inflammation such as non-steroidal anti-inflammatory drugs (nsaids) and statin

Keywords: atherosclerosis vascular inflammation resistin adiponectin 18fdg-pet
effects of medium chain triglyceride oil, versus olive oil, for weight loss

Conditions: Overweight

Summary: the primary aim of this research project is to determine whether the incorporation of food products containing medium chain triglyceride (mct) oil in a weight-loss program results in a different degree of weight-loss and total and regional fat mass loss than the incorporation of extra light olive oil. the secondary goals are to test whether there are differences in in metabolic risk profile changes between the 2 diets. we hypothesize that men and women who consumed mct oil as part of their weight loss program will lose more weight and body fat than those who consume olive oil in their weight loss diet.


Eligibility criteria:
inclusion criteria: * body mass index 27-33 kg/m2 * pre-menopausal women * weight stable for at least 6 months * normal score on brief symptoms inventory questionnaire exclusion criteria: * chronic disease * weight loss treatment * medication known to affect body weight * unstable blood pressure, glucose, lipid levels

Keywords: overweight obesity weight loss medium chain triglycerides cardiovascular disease risk
a study of diarrhea and intestinal flora changes caused by pyrotinib in breast cancer

Conditions: Breast Cancer

Summary: by measuring the intestinal flora abundance and bacterial count of patients in the early stage of using pyrotinib to clarify the relationship between diarrhea caused by pyrotinib and changes in intestinal flora in breast cancer patients, the correlation between the change of intestinal flora and the relief of diarrhea are also explored after two-cycle treatment.

in recent years, small-molecule tyrosine kinase inhibitors (tki) have achieved good results in anti-her2 therapy and have been widely used in clinical practice, such as breast cancer. however, such drugs can easily cause diarrhea and disorders of intestinal flora , may affect the efficacy of the drug and lead to the occurrence of other diseases.this study is to clarify the connection between the diarrhea caused by pyrotinib and the change of intestinal flora, pave the way for studying on whether the flora affects the efficacy of the drug and whether the flora should be supplemented appropriately in the future.

Eligibility criteria:
inclusion criteria: 1. female breast cancer patients aged 18-75 years. 2. ecog performance status of 0 to 1; 3. known hormone receptor status; 4. her2 positive breast cancer and previously reveived ≤2 anti-her2 therapy; 5. breast cancer patients are about to receive pyrotinib monotherapy or combined with trastuzumab/inetetamab and chemotherapy； 6. patients with adequate organ function before enrollment (no blood transfusion, no white blood cell or platelet-elevating drugs used within 2 weeks before screening): 1) blood routine:anc≥1.5×10\^9/l; plt≥90×10\^9/l; hb≥90 g/l；2)blood biochemistry: tbil≤1.5×uln;alt and ast ≤1.5×uln; alkaline phosphatase ≤ 2.5×uln; bun and cr≤1.5×uln；3) cardiac color doppler ultrasound:lvef≥55%；4) 12-lead ecg: qtcf \< 470 msec; 7. signed the informed consent form prior to patient entry, and have good compliance and are willing to cooperate with follow-up. exclusion criteria: 1. patients with severe heart disease or discomfor; 2. previous or ongoing use of her2-targeted tyrosine kinase inhibitors ; 3. inability to swallow, intestinal obstruction, or other factors that affect the taking and absorption of the drug; 4. allergy to pyrotinib; history of immunodeficiency, including hiv positive, active hbv/hcv, other acquired or congenital immunodeficiency disease and organ transplantation history; 5. patients during pregnancy or lactation, patients with childbearing potential tested positive in baseline pregnancy test, or patients unwilling to take effective contraceptive measures throughout the trial and 7 months after the last study medication; 6. patients with intestinal disease, serious concomitant diseases, or other comorbid diseases that will interfere with the planned treatment, or patients not eligible for this study judged by the investigator.
to assess safety, tolerability and pharmacokinetics of bi 416970 in healthy male volunteers

Conditions: Healthy

Summary: to investigate the safety and tolerability of bi 416970 and to assess the pharmacokinetics (pk) of single rising doses of bi 416970. a further objective is to assess the influence of cyp2c9 phenotype on the pk of bi 416970.


Eligibility criteria:
inclusion criteria: * healthy males according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory * age 18 to 50 years (incl.) * body mass index 18.5 to 29.9 kg/m2 (incl.) * signed and dated written informed consent prior to admission to the study in accordance with gcp and local legislation * known genotype of cyp2c9 isoenzyme exclusion criteria: * any finding in the medical examination (including blood pressure, pulse rate or electrocardiogram) is deviating from normal and judged as clinically relevant by the investigator * repeated measurement of systolic blood pressure outside of ranges 90-140 mmhg, diastolic blood pressure outside of ranges 50-90 mmhg, or pulse rate outside the range of 50 to 90 bpm * any laboratory value outside the reference range that the investigator considers to be of clinical relevance * any evidence of a concomitant disease judged as clinically relevant by the investigator * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication * diseases of the central nervous system (such as epilepsy), other peripheral neurological disorders or psychiatric disorders
a study to learn about the medicine called nirmatrelvir used in combination with ritonavir in people with weakened immune systems or at increased risk for poor outcomes who are hospitalized due to severe covid-19

Conditions: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2); Coronavirus Disease 2019 (COVID-19); Immunocompromised; Hospitalization; Child, Hospitalized

Summary: a study to learn about the medicine called nirmatrelvir used in combination with ritonavir in people with weakened immune systems or at increased risk for poor outcomes who are hospitalized due to severe covid-19


Eligibility criteria:
inclusion criteria: * meeting 1 of the 2 categories of covid-19 risk: * category a: immunocompromised * category b: non-immunocompromised, but with ≥2 risk factors * onset of signs/symptoms attributable to covid-19 ≤10 days prior to the day of randomization for non-immunocompromised participants (category b). * confirmed sars-cov-2 infection as determined by reverse transcription polymerase chain reaction (rt-pcr) or acceptable test method performed by a health care provider in any specimen collected within 48 hours prior to randomization. * hospitalized for inpatient care for the treatment of clinical manifestations of severe covid-19. * requirement for oxygen supplementation (via nasal cannula, mask, non-invasive ventilation \[niv\] or high flow oxygen) to maintain spo2 ≥94% at the time of screening and randomization. exclusion criteria: * critical illness, defined by ≥1 of the following: * requirement for mechanical ventilation or extracorporeal membrane oxygenation (ecmo) at randomization, or likely to require intermittent mandatory ventilation (imv) or ecmo within 12 hours of randomization . * multi-organ dysfunction/failure. * hemodynamically unstable, eg. septic shock, cardiac failure or requiring vasopressors. * participant not expected to survive 24 hours from time of randomization. * history of severe chronic liver disease * receiving dialysis of any kind or severe renal impairment * use of nirmatrelvir/ritonavir as an outpatient to treat the current covid-19 related illness ≤7 days of randomization

Keywords: covid-19 respiratory tract infections infections pneumonia, viral pneumonia virus diseases coronavirus infections coronaviridae infections nidovirales infections ribonucleic acid (rna) virus infections lung diseases respiratory tract diseases ritonavir hiv protease inhibitors viral protease inhibitors protease inhibitors enzyme inhibitors molecular mechanisms pharmacological action anti-human immunodeficiency virus (hiv) agents anti-retroviral agents antiviral agents anti-infective agents cytochrome p-450 cyp3a inhibitors cytochrome p-450 enzyme inhibitors paxlovid nirmatrelvir